The US Food & Drug Administration (FDA) has been developing regulations for the level of gluten in foods to be designated as “gluten-free” (Ref. 1), and opened the documents for public comment on August 3, 2011. The proposed “gluten-free” designation appears to be in sharp contrast to the FDA’s own Health Hazard Assessment (Ref. 2). Based on the scientific literature, we argue that the selection of a 20 ppm (parts per million) gluten limit does not create a sufficient margin of safety for people with a high degree of gluten-sensitivity. Instead, we propose a new, interim labeling of “Low-Gluten”.

Key Points:

The data on the specific levels of gluten that can be tolerated are ambiguous and preliminary

Given this uncertainty, a margin of safety should be applied because of the potential toxicity of gluten

The FDA proposed regulation is based on limits of assay sensitivity, rather than safety

“Gluten-free” will be mistakenly interpreted as “risk-free”

Instead, an interim standard of “Low-Gluten” should be adopted, using current assay methods. This would address the needs of manufacturers, while protecting consumers

Rationale:

Here, we provide a more detailed analysis of the issues:—

1. Background on the mechanism of celiac disease and gluten-sensitivity

For those not familiar with this field, celiac disease is a chronic inflammatory disease that can take years to develop. It can affect both the small intestine and other organs, and varies in severity from a “silent” form to an “active” form with often severe reaction to consumption of even minute amounts of gluten in foods such as wheat, rye, and barley (Ref. 3). While approximately 30% of the general population have a genetic susceptibility, only a small fraction actually develop the disease (approximately 1% of the population). The environmental or genetic factors that protect most people from developing celiac disease are not understood.

Celiac disease is highly under-diagnosed, because of the frequent lack of clear symptoms. In addition to celiac disease, there is a substantial fraction of the population who have a moderate sensitivity to gluten, but do not go on to develop the disease.

Since there is such a wide spectrum of reaction to gluten, and because celiac disease develops over a period of years, it has been difficult to define a threshold, or “safe”, level of gluten consumption. A detailed review can be found in the May, 2011 FDA internal report on the health hazards of gluten exposure (Ref. 2).

2. The ultimate goal: define standards for foods and ingredients which will be safe for people who are highly sensitive to gluten

Unlike mercury or dioxin, which are considered to be toxic to people in general, gluten-containing food products are consumed by almost everyone—but are only toxic to a small fraction of people. Foods labeled “cholesterol free” or “sodium free” provide useful guidance to aid the dietary choices of many people. In contrast, since gluten consumption by a celiac can have a major impact on health, and even life expectancy (Refs. 3, 4), the validity of a “gluten-free” food label carries substantial weight and responsibility.

We believe that gluten should be considered a potentially toxic food component rather than a food ingredient, such as cholesterol or sodium. Since the purpose of a gluten-free designation is to prevent celiacs from food-induced disease, then a stringent standard should be set, with an acceptable margin of safety based on the uncertainty and variability of its toxic effect on different people.

3. Problems in the measurement of gluten

“Gluten” is not a single substance: it is an umbrella term used to describe a set of different proteins. This complexity is increased further since, for example, each wheat plant has multiple genomes, and many different varieties of wheat are grown around the world. This results in a complex mixture of proteins which differ from variety to variety (Ref. 5).

In addition, food processing affects both the physical and chemical structure of gluten, and the validity of the ELISA for processed foods has not been proven.

Unlike a single hazardous substance like mercury, the relative safety of the different components in a complex mixture of proteins in “gluten” has not been established. In an ideal world, we would be able to measure “gluten”, but at present, the best that science can provide is to use a test which will give us an indication of the important toxic components in a food, not an accurate measurement.

4. Biological activity of different gluten components differ between patients

Numerous peptide fragments of the different proteins in “gluten” induce an immune response that is different for different people (Refs. 6, 7). While some peptides appear to be more reactive than others in stimulating an immune response, there is no single peptide fragment that has been proven to be representative of how gluten consumption provokes an immune reaction or leads to celiac disease. Indeed, the R5 ELISA assay commonly used for detection of gluten in food has never been validated as a predictor of disease severity (Ref. 8).

5. Different human populations differ in their sensitivity to gluten

The prevalence of celiac disease varies widely from country to country, resulting from a combination of genetic differences and environmental factors (Ref. 9). Within a group, individual celiac patients differ in their response to trace amounts of gluten (Ref. 10). It is therefore difficult to extrapolate from, say, the results from 12 subjects in a clinical trial, to the diverse population of 3 million people in the US with celiac disease.

6. Recovery from celiac disease

It is well known that some people, especially older adults, recover from celiac disease very slowly, or only partially (Ref. 11). It is still not clear if their intestines have suffered irreversible damage, or whether the trace levels of gluten present in the diet continue to stimulate the immune system. Since recovery can take years, celiacs need to err on the side of caution.

7. FDA health hazard assessment; margin of safety

The May, 2011 FDA internal report by the Office of Food Safety (Ref. 2) is a 93-page analysis of the available information on the clinical safety of gluten, in an attempt to define a safe level of gluten consumption. The FDA report is a revised version of a 2008 draft, and includes input from a December 2010 review by an external expert panel (Ref. 12). All the published studies involved small numbers of patients, using different study designs, making it impossible to draw a definitive conclusion about a safe threshold level of gluten consumption for celiacs.

(Unlike the drug and therapeutic sections of the FDA, where the agency can insist on rigorous clinical trials, the Office of Food Safety has to rely on existing published information.)

The authors developed different estimates of safety, including a Lowest Observable Adverse Effect Level and the Tolerable Daily Intake (TDI) (see Ref. 2, Appendix page B-14). A TDI of 0.4 mg gluten per day was derived using published data on measurable intestinal damage caused by gluten, and would correspond to the consumption of 400 g of food at a gluten level of 1 ppm.

The final sentence of the FDA Health Hazard Assessment report (Ref. 2, p. 46) states that:

In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with CD on a GFD [gluten-free diet] that protects the most sensitive individuals with CD and thus, also protects the most number of individuals with CD from experiencing any detrimental health effects from extended to long-term exposure to gluten.

It is important to note that a 1 ppm threshold would be beyond the capabilities of current assay, which creates a quandary for the FDA. The FDA has requested feedback on this proposal (comments should be submitted by October 3, 2011, see Ref. 1).

8. Examples of studies attempting to determine a safe dietary intake of gluten for celiacs

As explained earlier, there are remarkably few clinical studies which actually address the question of the specific dose of gluten that is safe for a celiac. Two publications were of particular concern to the FDA. One widely cited paper by Catassi et. al. (Ref. 10) was a small pilot study which attempted to define a safe intake of gluten. Thirteen celiac patients were tested with 50 mg gluten per day and showed a statistically significant level of mucosal damage compared to placebo. At the lower dose of 10 mg per day (which would correspond to 400 g food containing 25 ppm gluten), no statistically significant effects were observed. However, the authors noted:

The gluten microchallenge disclosed large interpatient variability in the sensitivity to gluten traces. Some CD patients showed a clear-cut worsening of the small-intestinal architecture after ingesting only 10 mg gluten/d[ay]…

and cautioned that:

Because of the limited number of patients, we were not able to reach firm conclusions about the potential toxicity of 10 mg gluten/d[ay], which remained a “gray” area.

9. Proposed FDA regulation disregards the available safety data

The proposed FDA regulation focuses on the current limit of detection of “gluten” (approximately 20 ppm using current assays). The FDA argues that the Hazard Assessment values that it developed are too uncertain to be taken into consideration (Ref. 1). In our opinion, this would be analogous to taking a known toxic chemical, and setting a high threshold for food contamination just because the available assay cannot detect lower levels of the toxin. Would the general public want to consume such a food with a label of “toxin-free”? We think not.

10. Risk of setting a “gluten-safe” threshold too high

What is an acceptable level of risk? We all face countless risks every day, and modify our behavior accordingly. Obviously, there is no way of guaranteeing that a food is safe for everyone.

For some unseen risks, such as toxins in the food supply, we rely on our government to provide guidance. If the FDA says that a food is “free” of a potential toxin, it sends a strong message to the consumer that the product is “safe”. Unfortunately, such a definitive position is not supported by the FDA’s own report.

The damage caused by gluten is at the microscopic level and often does not manifest as obvious symptoms, so we also need to be concerned about protecting celiacs from undetected damage. A margin of safety is therefore required to protect the public.

A margin of safety is also required, given the lack of validation that the current gluten assay is a predictor of biological activity.

We believe that a designation of “gluten-free” at 20 ppm will lull some people into a false sense of security, potentially resulting in an increased health risk.

In our opinion, a designation of Low-Gluten would be much more meaningful: it implies that there is a certain level of a toxin present, and that there is a potential risk to those most sensitive to the toxin.

11. Social and business impact

While many have protested the delay in developing a final FDA regulation for “gluten-free” food designation, given the complexity of the issues involved, the FDA has not been dragging its feet, but has been justifiably cautious. Having no standard at all is better than having a poor one that potentially could cause harm. We think that this caution and delay has actually been a good thing.

Even though celiac consumers want to have their food products clearly labelled “gluten-free”, this may not be a reasonable or achievable goal currently, or in the near future.

There is currently a boom in the consumption of “gluten-free” processed foods in the US, probably fueled by the (unproven) use of gluten-free products as a weight-loss aid. However, the increased availability of “gluten-free” foods is excellent news for celiacs, and food manufacturers are eager to have a more unified labeling standard, both to guide their manufacturing processes and to aid their marketing. We suspect that a designation of “low gluten” might have less marketing impact than “gluten-free”, but such a compromise would provide evidence for the manufacturers’ good faith intent to protect the consumer.

12. Gluten-free concentration standard versus dose per serving

One secondary point that hasn’t been discussed is that toxicity is proportional to the amount of gluten consumed, not the concentration. In other words, while a single threshold of 20 ppm may be convenient for manufacturers, the consumer is more concerned about amount per serving. The public has become comfortable with reading food labels and % Daily Value, so it should not be hard for the FDA to implement a similar system for gluten content. Since some foods are consumed in small amounts, this might have the added benefit of increasing the range of processed foods that can be available to the consumer on a low-gluten diet.

13. Our proposal

The FDA should abandon the hope of defining a true “gluten-free” standard (implying zero gluten) for now, but use the existing assays to define a Low-Gluten standard that will help the majority of people who are gluten-sensitive, while also providing some guidance to those who are extremely sensitive. Such a compromise would provide an interim solution, until a more rigorous definition of “gluten-free” can be obtained, and more extensive clinical trials are undertaken.

Summary:

The FDA has developed an internal report which recommends a “Tolerable Daily Intake” as 0.4 mg “gluten”, which corresponds to a gluten concentration of 1 ppm.

This is in sharp contrast to the proposed 20 ppm FDA standard for labeling a food as “gluten-free”.

The FDA has chosen to define “gluten-free” with respect to the current limits of detection, rather than on the basis of safety.

There is a substantial degree of uncertainty as to whether the current ELISA test for “gluten” is an accurate measure of gluten’s clinical effects in different individuals.

The current state of clinical science is insufficient to confidently define what is biologically gluten-free.

FDA standards should create a margin of safety, and err on the side of caution.

Setting a lax standard of “gluten-free” may actually pose a greater health risk than no standard at all.

FDA should instead create an interim designation of “Low-Gluten”, using currently available assays. This would be valuable today to people with mild gluten sensitivity, while balancing the needs of manufacturers.

“Low Gluten” foods may still be unsafe for many highly sensitive celiacs.

FDA regulations should be geared to amount per serving rather than a simple ppm concentration.

We recommend that the celiac community argue against the FDA’s proposal as it stands, but support a “Low-Gluten” labeling, instead.

More sensitive, validated assays need to be developed in order to support a future labeling standard of “gluten-free” that is based on predicted health risk

Larger clinical trials of celiac patients are required in order to establish the threshold of gluten sensitivity, and the variation from person to person.

Conclusion

We realize that this opinion may be controversial, but we believe that it would be better for the FDA to adopt no labeling standard for “gluten-free” foods than a poorly-designed one. Please help develop the public dialog by using the Comment Section below. (We can also be reached privately).

If you choose to give your feedback to the FDA, we encourage you to read the relevant reports first. Instructions for public comment can be found at:

46 comments to Should FDA Set 20 ppm Limit for Gluten-Free Food for Celiacs?

This is one of the most thorough reviews I’ve seen on the FDA proposed labels. I truly appreciate the time and energy taken to present your view on it! As an RD, much of the info is out of my ballpark, and I’m sorry that the FDA hasn’t actively explained the discrepancies thus far.

I, for one, am vehemently opposed to such a lenient definition for gluten free. I have pseudo anaphylactic and convulsive responses to gluten after having come close to death from extreme weight loss and muscle loss from gluten. My nerve endings were retracting to protect my spinal cord so I was losing feeling in my hands and feet. I had capillaries spontaneously explode. I was in continual excruciating pain. Once gluten-free, I slowly regained my life. I can tolerate no gluten. (And, to add to the controversy, I react to topical and inhaled gluten.) Granted, this may not be merely Celiac but a systemic reaction – but gluten is still the offender. While wheat-free listings do help to a degree, I also reaction to rye, barley and yes, oats.) I would be completely at sea and at a lost for what foods would be safe for me to consume if this becomes the standard.

While I am a statistical outlier as far as my reactions, I have had contact with others over the years who have “out of the box” reactions similar to mine. This definition of gluten free would be potentially deadly for me.

I agree. I, too, react seriously to any gluten. The last year or so I have barely been able to eat any “gluten free” foods, supposedly 20 ppm.

Thank you for your post here. It is excellent. It was posted on Celiac.com, but doubt many see it.
You can submit more than one comment. I have been told submitting many over the next month is important.
Do you think we have a chance against the big companies? I think we need to engage our congressmen in this battle.

In Europe we have the European Food Safety Authority who come out with Scientific studies, 27 Coeliac’s in all of Europe were tested (by the manufacturers with many ingredients derived from a gluten source) and of course these 27 had no reactions. Sadly this is not in the consumers interest, being a twice diagnosed coeliac with DH/Osteoporosis/Psoriasis/Eczma/ blood pressure up to 210/108 when glutened, walking difficulties as well as breathing difficulties when bloated.

“Gluten Free” is a misleading statement as it contains gluten,anything from a gluten source should be on any allergen labels as there are many coeliac’s world wide who cannot tolerate any gluten whatsoever.
Check out Commission Directive 2007/68/EC plus Annex IIIa also the European Food Safety Authority site putting Gluten in the search box, I did and this does not cover individuals sensitivity which makes eating and drinking a game of russian roulette, there is nothing to support people who cannot tolerate very low levels of gluten, socially or financially so this should be addressed taking into account of all types of Coeliac’s not just the profitable ones.

The selective studies you present here are in conflict with the much larger body of evidence which, again, support this level…in other words…you are cherry picking to find studies to support your personal position, and ignoring the forest.

Sadly studies and research do not cover all aspects of anything and can be manipulated to what is required.
I am a twice diagnosed Coeliac with a 45 year break in between diagnosis, I now react very badly to any amount of gluten from any source just as I did as a child. HLA-DQ2 Positive as well.
Research/studies etc do not explain my situation so sorry I only go by what applies to me.

Thanks, Scott, for joining the conversation. Since the 93-page FDA Hazard Assessment (May 2011) was published about three weeks ago, there seems to have been remarkably little public dialog about what it contains, or what it means. (A couple of notable exceptions are The Savvy Celiac, The Gluten-Free Dietitian, and Harris Whole Health). This is a shame, since I think almost everyone can agree that a lack of a clear regulation in the US has made life difficult for both celiacs and for the food manufacturers.

If you disagree with the methodology of the FDA safety analysis, you should, of course, voice this in your comments to the FDA. We are delighted that the FDA has created an open comment period, and note that there are numerous places where it has asked for specific input from the public. We were also impressed by the thoroughness of their report, especially considering the ambiguities they had to deal with.

We also welcome any specific feedback about the facts or interpretations in the 13 sections of our article, and will definitely take this into consideration when we submit our own response to the FDA.

My official diagnosis is gluten intolerance, but I react violently to ANY form of gluten. If something contains any grain product including by products (eg: xanthan gum) it should be labeled on the product to protect the consumer, in clear words that can be understood, not something that only a chemist would know. We are fragile enough with our health from the years of gluten ingestion and should have the right to choose foods that are not harmful to our health. Gluten is Gluten, which is a poison to us and we have the right to know if it is in our foods or not. Many of us have other health issues related to the gluten ingestion and work hard everyday to keep from ingesting it.

As a diagnosed celiac, with two children with celiac, all of whom are super sensitive to any trace amount of gluten, I agree that the proposed 20ppm labeling would not help my family in any way. We have all been made ill by one bite of an item that was subsequently tested at 7ppm.

Thanks for the ammo! I will be responding to the FDA soon. It felt awesome to finally see the word: “TOXIC” in writing!! I have been screaming it every day concerning this whole situation after almost losing my 16 year old daughter to a blood infection in March (6 weeks later=confirmed biopsy of Celiac)!! She had been anemic and on supplements for 2 years! Sick and slowly deteriorating before our eyes. Many Specialists missed it! After diet changes this Summer she has grown 1/2″ and put on 15#! Plus, she has more energy than ever! Why did she almost have to die to get help? Don’t they understand it’s not just a Fad?!

The absolute only remotely effective way to handle this, in my opinion (being celiac and having in a family of four celiacs, two of which are a 3 yr old and 1 yr old) is to label ANY cross-contamination possiblities, where any may exisit.

It is clear companies do not want to do this, for the simple fact that they are afraid of losing a lot of money because of anyone trying to eat completely gluten free.
To be honest, all four of us in my family get indescribably sick if we eat something cross-contaminated with gluten.

The absolute only responsible thing for the FDA to do, in light of this severe autoimmune disease now affecting millions and millions (esp. in the U.S.) – including young children and old alike, is to mandate that companies place a label stating “this product made in a facility that processes wheat” or “this product made near a wheat field”, as this is the height of sensitivity that some celiacs have.

How in heaven’s name is there any other conclusion to this, I ask you?
I would like very much not to feel like I’m walking on a land mine when I go to the grocery store or especially the health food store!! That’s, unfortunately worse, because these companies who are touting good health are not even properly labeling cross-contamination.

I am beyond sick to my stomach at calling each and every company regarding each ingredient I put into my children’s foods (ESPecially supplements, vitamins, flax oil, probiotics) or having them get violently ill (that’s right I said violently ill – my 3 and 1 yr olds) when a company like Garden of Life puts “gluten free” on their label and then my son has a reaction and suffers for weeks!

Or when Rice Dream doesn’t label that there’s possible “cross-contamination” due to the fact that their rice milk is MADE WITH BARLEY. They say it cooks out, but just ask my autistic, blown-up, watery-eyed, miserable, behavioral son if he can tell a difference! Or his gut-wrenched, miserable, maniacal mom, who’s trying to get him better!

This is abomiable and it needs to be stopped now.

Honestly, the bottom line is each and every company (because of this growing epidemic – if you don’t believe me just use google) needs to put “made in a facility that proccesses wheat” .. or “dairy” or “tree nuts”, etc.. I think the focus and the immportant thing however is that they label wheat, (and possibly dairy) because wheat intolerance is where all these other allergies and sensitivities appear to be stemming from.

And p.s… gluten is terrible for anybody. It causes inflammation, which is the root cause of all disease, including cancer, heart disease (heart attacks), leading to other autoimmune diseases – MS, MD, CIPD, Hashimoto’s thyroidism, you name it. The sad thing is, I’m ranting and raving and very few, if anyone is going to read and taking what I’m saying and actually put it to use.

I truly hope someone with depth and a conscience and someone with authority takes time to read and takes this post seriously. I am so sick and tired of dealing with this and the FDA is just making people sicker!!! Because people don’t even realize it!! That’s the truth.

[…] The Food and Drug Administration in the United States is in the process of re-defining what it means for a food to be gluten-free. Peter and Gillian Olins have written an excellent summary which can be found here. […]

I’m am relatively newly diagnosed (Feb 2011) but have been showing symptoms for years. Celiac runs in my family, but my (former) doctors refused to test me despite symptoms because I was obese, and “obese people don’t get celiac disease.” Since going completely gluten-free, I have come to realize that I react quite violently to ANY trace amount of gluten I eat. I don’t go out to eat anymore because of this. I don’t buy many gluten-free packaged foods either. I feel safest cooking and baking for myself because even the current voluntary standards for labeling foods gluten free aren’t reliable. I have not been tested for my specific sensitivity, but I’m confident in saying that a standard of 20ppm for a GF label would not benefit me in any way.

What a thoughtful and well-researched post about the proposed FDA labeling. You have brought up a lot of points that I have not seen summarized anywhere else. I hope you plan on adding your comments to the FDA docket. Thank you.

Thanks, Erin.
We plan to wait until close to the October 3 cutoff for comments to the FDA, since we hope that people will come forward with information and perspectives that will cause us to adjust and improve our comments. P&G

Diagnosed 10 yrs ago and incredibly sensitive to even the smallest gluten intakes – never purposeful. Recent scare for small bowel CA (EALT) – the labeling should not be misleading in any way. Gluten Free – should mean free (0 PPM). Chronic inflammation is bad for humans – even small amounts “low gluten” may be resulting in a smoldering low level inflammatory milieu in the jejunem only to explode with difficult to treat lymphoma.

Thank you so much for this. I have been “going on my gut” in feeling the 20ppm was not low enough. It made no sense to me since we know auto immune response only takes a minute amount to trigger it. I am most comfortable with this evaluation , even though it means life is more difficult and there are fewer option as to eating out and purchasing prepared foods. But I would rather prepare healthy food from fresh safe ingredients and be healthier than have “more choices” and poison myself. I very much want the labeling to reflect what’s safest for us all!

Let’s not throw the baby out with the bathwater. I am really sorry there are people who are ultra sensitive or may have undiscovered co-issues but the fact remains that the majority of Celiacs do not need a less than 20 ppm threshold.

I much prefer the opinion of medical experts than people who do not have the medical or science background to truly understand the issues. In Europe they have been quite successful with a 20 ppm gluten level (per the Codex) .This has been for decades.In addition my Celiac son has lived in Italy for months with no ill effects form the 20 ppm Codex.
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Kristine then added a link to the 1in133.org website:http://www.1in133.org/proposal/resources/assessment/

Kristine, the Codex to which you refer was set in 1981 at a level of 200 mg gluten/kg or 200 ppm – not 20 ppm. The European gluten-free labeling that you claim was in place for “decades” was, in fact, 10 times higher. This Codex regulation was amended in July 2008 to a 2-tier labeling system (“gluten-free” at 20 ppm or less gluten and “very low gluten” at 21-100 ppm gluten) in July 2008 and food manufacturers have until January 2012 to comply.http://www.coeliac.org.uk/healthcare-professionals/diet-information/codex-standard

I agree Deborah, it makes no sense to label an item GF when it contains even a tiny amount of gluten. It is vital that the food label reflects its true contents so that people affected by gluten can make properly informed choices.

In the UK, I was diagnosed with CD 6 years ago and at that time I found it very confusing that food with levels of up to 200 ppm gluten could be described as being GF. My dietitian had suggested I try these products containing Codex wheat starch as they were supposedly more palatable but I soon had to cut them out as I was still symptomatic. Since then, the labelling in the UK has undergone changes in readiness for a new EU law which comes into place in 2012 stating that gluten-free applies to food which has 20 ppm or less and very low gluten for foods between 21 and 100 pm. Whilst this is an improvement, I would recommend to the FDA in the US that they go one step further and label food with 20 ppm or less of gluten ‘very low gluten’ and label food with 21-100 ppm ‘low gluten’. This would be a more accurate description and enable people to shop and eat with confidence.

Thank you for your thoughtful perspective and recommendation as a celiac in Europe. It was very helpful that you put your comments in the context of what the Codex gluten threshold has been and what it will be in the near future with a two-tier labeling system. P&G

CAUTION:
——–
This topic is obviously an emotional issue for many of us, since it affects the health and well-being of a large number of people. We have started to receive feedback that speculates about the motivations of others, or questions their integrity. Comments like this will be edited or deleted.

We urge our readers to focus on the content of our article and provide constructive, specific comments. In responding to others, please be sure to read and understand what people are saying before jumping to conclusions.

Readers who are interested in the ambiguities around this topic are encouraged to read Ref. 10, by Catassi et al., and the excellent supporting references included in it. It is available for free download at http://www.ajcn.org/content/85/1/160.long

We hope that everyone wants the best outcome for as many people as possible!

Thanks for sharing that link. I found it interesting that some were not even able to complete the trial due to reactions and that one participant had to drop out when reacting to 10 ppm (if I read it correctly). Good study to read.

This study by Catassi et al (AJCN 2007) seems to be the ONLY study looking at how much gluten can be tolerated by celiacs. But it is only based on 39 adults!! And if you look at the data in Figure 2, you see that even in this small sample, there was variation in how different individuals responded to 10 mg gluten. Are we really going to base our standard on these 39 adults?

ALso, I am surprised that no one seems to be at all concerned that in the Proposed Rule, the FDA is not even going to mandate testing at 20 ppm…the way that the definition is currently written, companies need to either follow crirteria 1-3, OR test for 20 ppm gluten…

It’s unfortunate that I’m seeing the same adversarial stance being taken here that I’ve seen in other forums. Yes, some of us have atypical responses to gluten. Yes, for most of us the info is anecdotal at best. Statisticians know that outliers are ignored and stats gravitate towards the mean. While that is quite fortunate for many Celiacs and those with less severe gluten sensitivities or allergies, it leaves the rest of us in the lurch. How and why is there no sensitivity to the fact that some of us do react with more intensity than others? No report or trial is going to change that. It is what it is.

The adversarial stance only creates a rift in a common cause – our health. Seems to me that some are taking the “Well, this is gonna work for me, too bad it might kill you in the process (yes, I am that sensitive)” approach.

[…] (unlike everything I ever write, LOL), and had good links for supporting research, can be found at ultimateglutenfree.com. I hope that more people take note of them, and make some of their own letters in support of more […]

It took several months for me to finally determine where I was getting hidden gluten, that was keeping me sick with Celiac symptoms. I had been totally gluten free for many years. I accidentally discovered that the culprit was rice crackers that were label Gluten Free. Supposedly tested to be less then 20 ppm. I eliminated the rice crackers, and made no other changes in my diet and the symptoms went away, and never returned. I don’t know if the rice crackers actually contained more gluten then the label claimed, or if I was reacting to less then the 20 ppm that the FDA may allow. I can’t take any chances of getting that sick again, from hidden gluten, so I can’t really trust the gluten-free labels.

Just wanted to thank you again for this post – I can’t tell you how many people I’ve referred to look at it. Being super-sensitive, this issue is obviously a concern for me. And I have another condition that is very affected by the gluten in our gluten free food, but that has very few studies: gluten ataxia.

I have searched and searched, but found no studies ever done on the gluten threshold for neurological damage rather than gut damage. Celiac research centers tell me they know of no studies on this, either. But there is no reason to think that gluten ataxia is triggered with the same gluten threshold as enteropathy. In fact, one small study I discovered mentioned that some sufferers of gluten ataxia did not present with enteropathy at all, but still improved on a gluten free diet. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1738682/ )

A more honest label, of low gluten, might help those with gluten ataxia as well as more sensitive celiacs and those who may eat more gluten products in the erroneous belief that it’s completely safe.

I have not been able to find any information about a threshold for neurological damage, either. This might be important for prevention, since there is evidence that a gluten-free diet may be less effective in reversing some of the neurological effects of gluten.

Writing from Europe where I’ve been working with manufacturers for many years. As soon as a maximum level is established be it 20 ppm or 10 ppm. or even lower, manufacturers will take care in their sourcing and production to meet these levels. However a “guarantee” is only possible as long as tests can confirm a certain level. Currently testing goes as low as 5 ppm. There simply cannot be a guarantee below this level with current assays. So the question is do we want a guaranteed maximum level even as low as 5 ppm or do we want to lobby for a “no gluten what so ever”, which really no manufacturer can guarantee.

I agree that it is totally meaningless for some people to insist on “zero gluten”, since zero is something that cannot be measured. I think that the limit of “gluten-free” should involve a practical and cost-effective assay, and as you point out, the current limit appears to be 5 ppm.

[…] enough for people with celiac disease. Take a look at the following portion of an article from Ultimate Gluten Free that explains what this is all about. Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not […]

[…] have no more than 20 parts per million of gluten. Last year we published a blog entitled “Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not Adequately Protect the Food Supply for …“, and followed up with a “Letter to FDA on Labeling of Gluten Free Foods for Celiac […]

[…] on the subject of preferred FDA labeling for gluten-free foods in the US, in a blog entitled: Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not Adequately Protect the Food Supply for … After considering the comments that we received, we refined our position and submitted our […]

[…] FDA Proposes 20 ppm Limit for Gluten-Free Foods Almost everyone in the celiac community is aware of the proposed FDA standard for “gluten-free” food labeling—foods must contain less than 20 ppm gluten. This standard is based on very limited clinical studies measuring the safety of the intact protein. As described in our article last year, there are significant challenges in devising a meaningful standard for ensuring that gluten-free foods are safe for celiacs (Ref. 3). These assays provide an estimate of the total amount of gluten in a food, but they are not a direct measure of food safety, and may not be adequate for the needs of all celiacs. Currently, there are excellent assays available for measuring the level of intact gluten (or related proteins) in foods. The “R5 Mendez Sandwich ELISA” is the preferred assay selected by the FDA in its draft regulations. These assays are an attempt to provide standards that will ensure safety for the majority of celiacs. The assay is based on an antibody, called R5, that recognizes a specific short sequence of 5 amino acids. Since this sequence is present in many of the components on gluten, it provides a convenient way to estimate the amount of gluten present. Related proteins from barley or rye are fairly similar in structure to wheat gluten; the antibody cross-reacts with these proteins, and can be used to estimate the amount of “gluten” in these grains. Ref. 3: Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not Adequately Protect the Food Supply for Celiacs http://ultimateglutenfree.com/2011/08/fda-20-ppm-regulation-gluten-free-food-celiac-disease/ […]

[…] U.S. we are still waiting for a final regulation from the government, but the latest public draft FDA regulation for gluten in food also sets a cutoff value of less than 20 ppm for a food labeled as […]

My daugher has severe wheat allergy and celiac disease. Ingestion of wheat causes anaphylaxis and CD symptoms and airborn or skin exposure causes swelling, hives, itching, headache, etc. I have wondered why after following a gluten free diet and purchasing items that are labeled “gluten free”- that my daughter continues to exhibit signs of exposure including daily swelling, itching and stomach ache. I finally found out this week about the PPM and that basically she’s been ingesting wheat/gluten in trace amounts over the past 2 years and that is what most likely is causing her issues. She needs to eat food that is 100% gluten free no trace amount – so this has become quite an issue. Thanks for the information it is very helpful!

Hi CK,
The FDA regulation was designed to address the needs of people with celiac disease.
Wheat allergy depends on a completely different mechanism, and I’m not sure if the “20 ppm gluten” standard is sufficient to prevent allergy.

Real easy, an item either has gluten or doesn’t. End of story. Low gluten designations just confuse the general public and lead to the statement by well meaning friend “oh it won’t hurt, it has just a little gluten.”

I understand where you’re coming from, but I don’t think that it’s that simple. When the FDA finally issued its gluten-free labeling rule last year (discussed here: http://ultimateglutenfree.com/2013/08/gluten-free-labeling-rules-finalized-by-fda-what-do-they-mean-and-who-benefits/), its main justification for a 20 ppm cutoff was that the typical assays available are not good at detecting lower levels. There is, of course, no way to say that a food is absolutely free of something—only that the level is below a certain cutoff. As I hope we explained in our blog, there is very little published data about a “safe” level of gluten for celiacs. In fact, one reasonable explanation for why many celiacs respond poorly to a “GF” diet is that exposure to trace levels of gluten might be sufficient to keep the disease active. Our point about “low gluten” was that 20 ppm may not be the same as gluten-free. In other words, your comment may actually be close to the mark: “oh it won’t hurt, it’s labeled GF”.

No doubt, in the future, we will have more sensitive assays, and will be interesting to see if the regulatory authorities will be willing to adjust the cutoff.